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Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
OPT-822/OPT-821
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis
  • Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy.

OR

  • Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis)
  • Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery .

Exclusion Criteria:

  • Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria.
  • Subjects who are currently receiving any other concomitant anticancer therapy.
  • Subjects with evidence of extra-abdominal metastasis.

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPT-822/OPT-821

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Disease Recurrence Rate

Full Information

First Posted
May 6, 2014
Last Updated
May 6, 2014
Sponsor
Mackay Memorial Hospital
Collaborators
OBI Pharma, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02132988
Brief Title
Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer
Official Title
An Open Labeled Phase II Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital
Collaborators
OBI Pharma, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OPT-822/OPT-821
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
OPT-822/OPT-821
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
Until disease progression or up to 5 years after the enrollment
Secondary Outcome Measure Information:
Title
Disease Recurrence Rate
Time Frame
At 2 years after the enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy. OR Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis) Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery . Exclusion Criteria: Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria. Subjects who are currently receiving any other concomitant anticancer therapy. Subjects with evidence of extra-abdominal metastasis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Chen
Phone
886-2-25433535
Ext
3941
Email
fionaeg0528@gmail.com
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Chen
Phone
886-2-25433535
Ext
3941
Email
fionaeg0528@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih-Lung Chang, MD
First Name & Middle Initial & Last Name & Degree
Yuh-Cheng Yang, MD

12. IPD Sharing Statement

Learn more about this trial

Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer

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